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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05950282
Other study ID # 2023-0060
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date December 2026

Study information

Verified date September 2023
Source Lilli Health
Contact Ali M Chappell, PhD, MS, RD
Phone 8064417275
Email achappell@lillihealth.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.


Description:

This study aims to investigate the significance of measuring fasting insulin and the homeostatic model assessment of insulin resistance (HOMA-IR) in identifying metabolic health across various demographic and clinical factors. Specifically, the study will examine the influence of age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis on insulin levels and insulin resistance as essential indicators of metabolic dysfunction. Metabolic health disorders, such as insulin resistance and impaired glucose metabolism, are known to be associated with an increased risk of developing conditions like type 2 diabetes, cardiovascular diseases, and metabolic syndrome. Traditionally, glucose levels have been used to assess metabolic health; however, fasting insulin and HOMA-IR provide valuable insights into the underlying insulin dysregulation that precedes the onset of these conditions. Disparities in insulin levels have been observed across different racial and ethnic groups. These variations may arise from genetic predispositions, differences in lifestyle, or a combination of both, thus highlighting the need to explore these factors comprehensively. BMI, a measure of body composition, has been strongly associated with elevated insulin levels and insulin resistance. Individuals with obesity often exhibit dysregulated insulin metabolism, leading to higher fasting insulin and HOMA-IR values. Furthermore, PCOS, a common endocrine disorder affecting reproductive-age women, is frequently associated with insulin resistance. Studying the insulin profiles among women with PCOS will shed light on the potential metabolic implications and help tailor interventions for this at-risk population. The study will employ a cross-sectional design, enrolling a large sample of participants from diverse backgrounds. Fasting insulin levels will be measured using standardized laboratory methods, and HOMA-IR scores will be calculated based on fasting insulin and glucose values. Statistical analyses, including regression models and subgroup comparisons, will be conducted to assess the associations between fasting insulin, HOMA-IR, and the demographic and clinical factors of interest. This research aims to emphasize the importance of incorporating fasting insulin and HOMA-IR measurements alongside glucose assessments to enhance the identification and understanding of metabolic health disorders. The findings are expected to contribute to a more comprehensive approach in diagnosing, managing, and preventing metabolic diseases, ultimately leading to improved patient outcomes and public health interventions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date December 2026
Est. primary completion date October 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age: Participants aged 18+ years. - Sex: Both males and females. - Race/Ethnicity: Participants from diverse racial and ethnic backgrounds - BMI: Participants with a range of body mass index (BMI) values - PCOS Diagnosis: Participants with and without a confirmed diagnosis PCOS based on established diagnostic criteria. Exclusion Criteria: - Age: Participants below 18 years - Sex: None. Both males and females are included. - Race/Ethnicity: None. Participants from all racial and ethnic backgrounds are included. - Endocrine Disorders: Participants with other endocrine disorders affecting insulin levels, such an insulin secreting tumor.

Study Design


Locations

Country Name City State
United States Lilli Health Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Lilli Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of Fasting Insulin levels and HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) scores among different groups stratified by age, sex, race/ethnicity, BMI, and PCOS (Polycystic Ovary Syndrome) diagnosis. The primary objective is to investigate the association between these measures and the specified demographic and clinical factors, providing insights into the variations and potential disparities in insulin resistance across different subgroups. 3 years
Secondary Identify any significant interactions or relationships between the primary outcomes (Fasting Insulin and HOMA-IR) and the demographic and clinical factors, including age, sex, race/ethnicity, BMI, and PCOS diagnosis. The secondary outcome measure will provide a comprehensive understanding of how various factors may influence insulin resistance and contribute to its heterogeneity in different populations. 3 years
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